Inspections, Compliance, Enforcement, and Criminal Investigations
All Sea's Seafood of Florida, Inc. 17-Oct-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
October 17, 2006
David A. Goldstein, President
All Sea's Seafood of Florida, Inc
7830 Wiles Road
Coral Springs, FL 33067-2039
Dear Mr. Goldstein:
We inspected your seafood processing facility, located at the above address on September 5-7, 2006. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 123 & 110). In accordance with 21 CFR§ 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your canned pasteurized crabmeat and refrigerated vacuum packed smoked salmon are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and you must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). A food safety hazard is defined in 21 CFR § 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However your firm does not have a HACCP plan for:
a. Canned pasteurized crabmeat to control the food safety hazards of pathogen growth and toxin formation, specifically Clostridium botulinum (FDA 483, Item #1a).
b . Refrigerated vacuum packaged smoked salmon to control the food safety hazards of pathogen growth and toxin formation, specifically Clostridium botulinum (FDA 483, Item #1 b).
You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures of documenting the cooler and freezer temperatures for the critical control point of storage and holding to control scombrotoxin formation listed in your HACCP plan for the storage of histamine forming species. These records are missing from July 2006 to the date of the inspection. It should be noted that this is a repeat observation from the inspection FDA conducted at your facility in April 2005.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as revised HACCP plans, verification records, revised labels, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407) 475-4763.
Emma R. Singleton
Director, Florida District